Naturally, these medicines need to be regulated

IT’S BEEN 10 years since SA’S Medicines Control Council (MCC) announced its “call-up” of products generally referred to as “complementary medicines”.

These are “natural” products which do not have to be registered as medicines, yet most make healthrelated claims.

The intention was for the MCC to audit these products during a sixmonth period in 2002, but all that’s happened is that the list of products has grown into a very long one in the past decade, with not a single product having been evaluated for safety, quality or efficacy.

But this hasn’t stopped some of the manufacturers and importers from claiming in their marketing that their product is “registered with the MCC” – a few going as far as to falsely use their MCC “acknowledgment of receipt” number as a registration number, thereby creating the impression that the product has the body’s stamp of approval, when if fact it hasn’t been assessed at all.

In a written response to a parliamentary question, the Health Minister said in October 2010 that about 155 000 submissions for complementary medicines had been received since the publication of the call-up notice of February 2002.

As for why none of them had been evaluated in any way, the min- ister said the procedures and guidelines were not yet in place.

The only authority which ever calls upon the manufacturers or importers to substantiate their product claims is the Advertising Stan- dards Authority (ASA), and then only when someone lodges a formal complaint of misleading advertising.

That person is, more often than not, Dr Harris Steinman of Cape Town, who for much of the past decade has made it his business to lodge complaints against scores of “complementary” products, mostly for weight loss.

Most of his complaints have been upheld by the ASA’S Directorate, which has ordered the companies in question to remove the misleading claims from their products’ packaging or advertising.

Last week the SA Association for Responsible Health Information (ARHIA), of which Steinman is a member, released a statement marking the 10th anniversary of the complementary medicines call-up.

“What this means is that for 10 years people making and marketing complementary medicines have done so with relative impunity, profiting off South Africans who have been convinced that they should use these products to improve their health and quality of life,” said Professor Roy Jobson of Rhodes University’s pharmacy faculty on behalf of ARHIA.

“For registered medicines, the guarantee (of safety and efficacy) comes from the MCC.

“But for unregistered medicines where there is no such guarantee from the MCC, pharmacists have to personally make the decisions as to what to sell, based only on information provided by the manufacturers of the products.”

The association said it believed that evidence of efficacy could not be provided for most of the products on the list, “which poses a serious public health risk to those who live in South Africa”.

ARHIA called on the MCC, the Health Minister, the Pharmacy Council, the Allied Health Professions Council and the Director-general of Health to collaborate in remedying this situation as soon as possible.

“We note that draft complementary medicines regulations were published for comment in 2011, and although they clarify to some extent how these substances might be controlled, they are silent on implementation and a time frame for their implementation.”

This week yet another of Steinman’s complaints against the marketing claims of a weight loss product was upheld by the ASA Directorate.

The product is Dis-chem Pharmacies’ Dis-chem Gold Herbal Weight Loss Formula, which claims to be “fast acting with Hoodia and Slimaluma”.

Steinman contended that there was insufficient evidence to support the weight loss claims of either the individual ingredients or their combination.

He added that the product name implied that it had the ability to induce weight loss, which he said was not true.

Steinman also said that not all the ingredients were herbal, and that the first-ever peer-reviewed study on Hoodia had shown that it has no effect on weight-loss or appetite suppression.

Responding, Dis-chem pharmacies told the ASA Directorate that based on scientific research and reports on the product’s active ingredient, it believed it to be a bona fide product, and that Steinman’s complaint was unfair and unfounded.

The company submitted documentation, some of it untitled and unreferenced, purporting to prove the efficacy of ingredients such as Hoodia gordoni, guarana, kola nut, “Slimaluma” and Caralluma fimbriata extract.

The Directorate said that it required unequivocal, product-spe- cific verification because the weightloss claims are made for the product as a whole, and consumers are only able to buy the whole product.

“There is nothing before the Directorate to indicate that there was product-specific research or that it exists,” it said in its ruling.

“The respondent has also not submitted independent research documents as evidence that the ingredients as mentioned on the packaging are effective in the dosage used in the product, and consumed by consumers, and that the said ingredients do not also contra-indicate each other.”

In short, the Directorate upheld Steinman’s claim, ruling that DisChem withdraw the name for its product – Gold Herbal Weight Loss Formula – as well as any references to weight loss, within three months.